Back to resultsMR Imaging of the 3D Inguinal Hernia Scaffold ProFlor
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ProFlor inguinal hernia device
Sponsored by
About this trial
This is an interventional diagnostic trial for Inguinal Hernia
Eligibility Criteria
Inclusion Criteria:
- patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor
Exclusion Criteria:
- all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor
Sites / Locations
- University of Palermo - Italy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Short term post inguinal hernia repair with ProFlor
Mid term post inguinal hernia repair with ProFlor
Long term post inguinal hernia repair with ProFlor
Arm Description
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 1 to 3 months before to assess tissue incorporation into the 3D scaffold
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 4 to 7 months before to assess tissue incorporation into the 3D scaffold
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor after 8 months and beyond to assess tissue incorporation into the 3D scaffold
Outcomes
Primary Outcome Measures
tissue incorporation into ProFlor in the short term postop.
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
tissue incorporation into ProFlor in the mid term postop.
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
tissue incorporation into ProFlor in the long term postop.
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04762264
Brief Title
MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor
Official Title
A 3D Regenerative Scaffold for Inguinal Hernia Repair. MR Imaging and Histological Cross Evidence.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor
Detailed Description
The biological response of the 3D inguinal hernia scaffold ProFlor has been evaluated through MRI signal intensity (SI) at three defined post-implantation stages: short, mid and long term. The SI of ProFlor has been compared to the SI of the neighbouring muscles and fat. As additional proof, histology of tissue specimens excised at the identical post-implantation stages from porcine models in the fame of a previous experimental attempt were also evaluated. The results of this experimental trial have ben already published in 2011 - ref: A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artificial Organs 2011;35(8):E181-E190
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short term post inguinal hernia repair with ProFlor
Arm Type
Active Comparator
Arm Description
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 1 to 3 months before to assess tissue incorporation into the 3D scaffold
Arm Title
Mid term post inguinal hernia repair with ProFlor
Arm Type
Active Comparator
Arm Description
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 4 to 7 months before to assess tissue incorporation into the 3D scaffold
Arm Title
Long term post inguinal hernia repair with ProFlor
Arm Type
Active Comparator
Arm Description
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor after 8 months and beyond to assess tissue incorporation into the 3D scaffold
Intervention Type
Device
Intervention Name(s)
ProFlor inguinal hernia device
Intervention Description
Device follow up after inguinal hernia repair with ProFlor
Primary Outcome Measure Information:
Title
tissue incorporation into ProFlor in the short term postop.
Description
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
Time Frame
1- 3 weeks post implantation
Title
tissue incorporation into ProFlor in the mid term postop.
Description
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
Time Frame
4-7 months post implantation
Title
tissue incorporation into ProFlor in the long term postop.
Description
evidencing the quality of the biologic response in ProFlor through signal intensity assessment collected in the T1 TSE axial sequence and measured with region-of-interest application (ROI) positioned on three different zones, respectively in muscle, fat and tissue ingrown within ProFlor
Time Frame
8 months post implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients who underwent inguinal hernia repair with the 3D inguinal hernia scaffold ProFlor
Exclusion Criteria:
all individuals who underwent inguinal hernia repair withouth the 3D inguinal hernia scaffold ProFlor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Amato
Organizational Affiliation
University of Cagliari
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Palermo - Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
upon request within
IPD Sharing Time Frame
one year after study completion
IPD Sharing Access Criteria
email contact
Citations:
PubMed Identifier
21752035
Citation
Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
Results Reference
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PubMed Identifier
25626584
Citation
Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
Results Reference
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PubMed Identifier
30318605
Citation
Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.
Results Reference
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PubMed Identifier
32169570
Citation
Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.
Results Reference
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Learn more about this trial
MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor
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